Helicobacter pylori eradication therapy and clinical outcomes in Parkinson's disease: a double-blind randomized placebo-controlled trial.

BACKGROUND: Helicobacter pylori (HP) infection has been implicated in modifying treatment response and clinical outcomes in Parkinson's disease(PD). This study aimed to evaluate the effect of HP eradication therapy on motor symptoms, non-motor symptom burden, and quality of life in patients with PD. METHODS: We conducted a double-blind, randomised, placebo-controlled trial in which HP-positive adults with PD were randomised (1:1) to standard triple eradication therapy (omeprazole 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg, each twice-daily for 14 days) or matched placebo. The primary outcome was the MDS-Unified Parkinson's Disease Rating Scale(MDS-UPDRS) Part III motor score in the ON medication state at 12 weeks. Secondary outcomes included total MDS-UPDRS score, Non-Motor Symptoms Scale (NMSS) score, and Parkinson's Disease Questionnaire-39 (PDQ-39) summary index score. RESULTS: Out of eighty participants who underwent urea-breath testing, 34 tested positive. Of them, 30 participants were randomised to the two treatment groups. The primary outcome did not differ significantly between groups at 12 weeks (mean difference -3.9; 95% CI -15.5 to 7.6; p=0.49), which was unchanged after adjustment for baseline scores (p=0.13). No significant between-group differences were observed in total MDS-UPDRS score(mean difference -0.13; 95% CI -22.1 to 21.8; p=0.99), NMSS score(mean difference 23.3; 95% CI-8.8 to 55.4; p=0.15), or PDQ-39 scores(mean difference -7.1; 95% CI -35.4 to 21.1; p=0.61). CONCLUSIONS: HP eradication therapy did not improve motor symptoms, non-motor symptom burden, or quality of life in PD patients over 12 weeks. These findings do not support routine HP eradication as an adjunctive strategy for improving PD symptom control. TRIAL REGISTRATION: CTRI/2019/04/018524.